EP2736454B1 - System zum laden einer faltbaren herzklappe - Google Patents

System zum laden einer faltbaren herzklappe Download PDF

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Publication number
EP2736454B1
EP2736454B1 EP12746185.3A EP12746185A EP2736454B1 EP 2736454 B1 EP2736454 B1 EP 2736454B1 EP 12746185 A EP12746185 A EP 12746185A EP 2736454 B1 EP2736454 B1 EP 2736454B1
Authority
EP
European Patent Office
Prior art keywords
heart valve
recess
delivery device
compression member
support member
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP12746185.3A
Other languages
English (en)
French (fr)
Other versions
EP2736454A1 (de
Inventor
Brett A. HILLUKKA
Khoi A. LE
Ralph J. Thomas
Valerie J. Glazier
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
St Jude Medical Cardiology Division Inc
Original Assignee
St Jude Medical Cardiology Division Inc
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Publication date
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Publication of EP2736454A1 publication Critical patent/EP2736454A1/de
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Publication of EP2736454B1 publication Critical patent/EP2736454B1/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • A61F2/9525—Means for mounting a stent or stent-graft onto or into a placement instrument using a funnel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0095—Packages or dispensers for prostheses or other implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0007—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting length
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0064—Sets comprising a plurality of prosthetic parts of different sizes
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y10T29/49908—Joining by deforming

Definitions

  • the present disclosure relates to prosthetic heart valve implantation and, more particularly, to assemblies and methods for loading a self-expanding collapsible heart valve into a delivery device.
  • Prosthetic heart valves may be formed from biological materials such as harvested bovine valves or pericardial tissue. Such valves are typically fitted within a stent, which may be inserted into the heart at the annulus of the compromised native valve to replace the native valve. To perform such insertion procedure using a minimally invasive technique, it is typically necessary to compress the stent to a reduced diameter for loading into the delivery device.
  • the stented valve is preferably preserved in the open condition for storage as compression of the valve material for extended periods compromises the integrity of the biological valve. It is therefore necessary to crimp the valve, or reduce its diameter for loading in the delivery device, in the operating arena.
  • the assembly may include a compression member having a first open end with a first diameter, a second open end with a second diameter less than the first diameter, and a wall which decreases in diameter from the first open end to the second open end, the wall defining an open space adapted to receive the heart valve; a support member having a base on a first end and a recess on a second end, the recess having a fixed depth between a support surface of the recess and an open end of the recess, the recess being adapted to receive an end of the heart valve, the support member and the compression member being movable relative to one another between an initial position in which the base of the support member is relatively far from the first open end of the compression member and an operative position in which the base of the support member is relatively close to the first open end of the compression member, wherein movement of the support member and the compression member from the initial position to the operative position push
  • the assembly may further include a tubular extension on the second open end of the compression member, the tubular extension having a lumen therethrough; and a first seal interposed between the delivery device and the tubular extension of the compression member.
  • the seal may include an O-ring.
  • the assembly may further include a locking assembly for locking the compression member to the support member.
  • the locking assembly may include a male connecting member on one of the support member or the compression member, and a female connecting member on the other of the support member or the compression member for mating with the male connecting member.
  • the male connecting member may include a plurality of pins extending in radial directions from the longitudinal axis of the one of the support member or the compression member, and the female connecting member may include a plurality of features on the other of the support member or the compression member adapted to mate with the plurality of pins.
  • the delivery device may include a tip, a retaining element, a compartment defined between the tip and the retaining element and adapted to receive the heart valve, and a distal sheath movable between a closed position fully covering the compartment and an open position uncovering the compartment.
  • the heart valve may include a stent, a valve assembly supported by the stent, and at least one retainer at one end of the stent, the heart valve having an expanded condition and a collapsed condition.
  • Methods according to this aspect of the present invention may include configuring a support member to receive an end of the heart valve, the support member having a base on a first end and a recess on a second end, the recess having a fixed depth between a support surface of the recess and an open end of the recess, the configuring step including assembling a spacer in the recess so that the recess has a depth between a support surface of the spacer and the open end of the recess which is less than the fixed depth; inserting the end of the heart valve in the expanded condition into the recess of the support member; advancing the support member and a compression member toward one another, the compression member having an inner surface which decreases in diameter uniformly from a first open end to a second open end, the advancing step including advancing the heart valve through the compression member until the at least one retainer protrudes from the second open end of the compression member; positioning the delivery device in an initial position in a constricting member, the constricting member having a first
  • the method may further include filling at least a portion of the compression member with a sterile liquid before moving the distal sheath of the delivery device to the closed position to remove air from the heart valve and the delivery device.
  • kits for delivering a self-expanding prosthetic heart valve to an implantation site in a patient the heart valve being one of a plurality of different sizes.
  • the kit may include a delivery device including a tip, a retaining element, a compartment defined between the tip and the retaining element and adapted to receive the heart valve, and a distal sheath movable between a closed position fully covering the compartment and an open position uncovering the compartment.
  • the kit may further include a compression member, a support member, a constricting member and a spacer as described above.
  • the fixed depth of the recess may be adapted for use with a heart valve of a first length, and the second depth of the recess may be adapted for use with a heart valve having a length less than the first length.
  • the kit may include a plurality of spacers adapted for assembly in the recess, each spacer being adapted to reduce the depth of the recess by a selected amount, the selected amount for one spacer being different from the selected amount for each of the other spacers.
  • proximal refers to the end of the catheter assembly, or portion thereof, which is closest to the operator in use, and to the end of the loading assembly which is closest to the proximal end of the catheter assembly when the loading assembly is assembled on the catheter assembly during a valve loading procedure.
  • distal refers to the end of the catheter assembly, or portion thereof, which is farthest from the operator in use, and to the end of the loading assembly which is closest to the distal end of the catheter assembly when the loading assembly is assembled on the catheter assembly during a valve loading procedure.
  • the present disclosure relates to assemblies and methods for loading a self-expanding stent or a collapsible prosthetic heart valve into a minimally invasive delivery device.
  • An exemplary minimally invasive delivery device 10 is illustrated in FIGS. 1 and 2 .
  • an exemplary delivery device 10 for transfemoral delivery of a collapsible prosthetic heart valve (or other types of self-expanding collapsible stents) has a catheter assembly 12 for delivering the heart valve to and deploying the heart valve at a target location.
  • the catheter assembly 12 includes a compartment 23 defined between an atraumatic tip 32 of the delivery device 10 and a retaining element 26.
  • a support shaft 28 is connected between tip 32 and retaining element 26 and defines the length of compartment 23.
  • a distal sheath 30 is slidably arranged relative to the compartment 23 so that, in a distalmost or closed position in which the distal end 21 of the sheath abuts atraumatic tip 32, the sheath covers the prosthetic heart valve and retains it for delivery to the target site, and in a proximal or open position in which the distal end 21 of the sheath is spaced from the atraumatic tip 32, the sheath uncovers the prosthetic heart valve for deployment at the target site.
  • An inner tube 16 having a lumen therethrough extends from a hub 14 at or near its proximal end to a distal end which may be connected to retaining element 26.
  • the distal end of inner tube 16 may extend through retaining element 26 and support shaft 28 for connection to atraumatic tip 32.
  • the distal end of inner tube 16 is connected to compartment 23 so as to define a fixed distance between hub 14 and the compartment.
  • the lumen through inner tube 16 is sized to slidingly receive a guidewire (not shown) for use in guiding the delivery device to the target site.
  • inner tube 16 may be provided with a hemostasis valve (not shown) for preventing, or at least hindering, blood flow out from the inner tube.
  • Hub 14 is adapted for connection to another system or mechanism, such as an operating handle (not shown) for displacing the distal sheath 30.
  • an operating handle not shown
  • Mechanisms for displacing the distal sheath 30 between its proximal and distal positions are described in International Patent Application Publication No. WO/2009/091509 .
  • a retaining ring 15 may be mounted on the inner tube 16 near hub 14.
  • Catheter assembly 12 further includes an outer shaft 20 which is connected at its distal end through a tapered transition member 24 to the proximal end of distal sheath 30, and at its proximal end to the operating handle (not shown).
  • a Y-connector 18 may also be connected at the proximal end of outer shaft 20, and may include a hemostasis valve for hindering blood flow out from between the inner tube 16 and the outer shaft 20.
  • the Y-connector 18 may also be coupled to a fluid source for flushing the outer shaft 20, injecting contrast media during a prosthetic valve implantation procedure, and the like.
  • the retaining element 26 may include a plurality of recesses 27 located around its periphery.
  • the recesses 27 are spaced apart from one another and each is sized and shaped to receive a tab or retainer on one end of the prosthetic heart valve to maintain the prosthetic heart valve in assembled relationship with the delivery device 10, to minimize longitudinal movement of the prosthetic heart valve relative to the delivery device during unsheathing and resheathing procedures, to help prevent rotation of the prosthetic heart valve relative to the delivery device as the delivery device is advanced to the target site and during deployment, and to maintain the alignment of the stent cells and prevent them from becoming tangled.
  • FIG. 4 shows a conventional bioprosthetic valve 100 designed to replace a native aortic valve.
  • the valve 100 has a collapsed condition and an expanded condition and may be formed from a collapsible framework or stent 102, with a valve assembly 104 internally connected to the stent.
  • the stent 102 may be formed from any suitable biocompatible material, such as nitinol or any other suitable elastic or shape memory material, and may include an annulus section 106, an aortic section 108, and a sinus section 110 located between the annulus section and the aortic section.
  • the aortic section 108 may have a larger cross-section than the annulus section 106.
  • the valve assembly 104 conventionally includes a plurality of leaflets 112 and a cuff 114 attached to the stent 102.
  • the leaflets 112 and the cuff 114 may be formed from a biocompatible polymer, from natural tissue such as bovine or porcine pericardial tissue, or from other appropriate biocompatible materials.
  • the valve assembly 104 is preferably connected to the stent 102 generally within the annulus section 106.
  • the valve 100 may include a plurality of tabs or retainers 118 at spaced positions around one or both ends of the stent 102 for engagement with the retaining elements 26 of the delivery device 10 as described above.
  • the retainers 118 may also be utilized to collapse the valve 100 for loading into the delivery device 10, as will be discussed below.
  • Valves 100 may be provided in a number of different diameters depending upon the anatomy of the patient into which the valve is to be implanted.
  • the stent 102 of the valve will generally elongate as the valve is crimped to its collapsed condition.
  • the amount of elongation generally will be directly related to the diameter of the stent.
  • the amount of elongation will be greater than that for smaller diameter stents.
  • the present invention accommodates this difference in elongation as the heart valve is collapsed and loaded into delivery device 10.
  • the valve 100 is preferably stored in its expanded or open condition as the bioprosthetic valve assembly 104 may be compromised by storage in a collapsed condition for extended periods of time. As such, it is necessary to crimp the valve 100 into a collapsed condition of reduced cross-section for loading into the delivery device 10 at the latest possible time prior to the surgical implantation procedure. In order to effectively limit the time period the valve 100 is collapsed, the crimping process is preferably conducted in the operating arena by the surgeon, interventional cardiologist or surgical assistant using a specialized assembly.
  • FIGS. 5-8 illustrate a loading assembly 200 according to an embodiment of the present invention, the loading assembly generally including a compression member 202 and a support member 204 adapted to be coupled to one another, a constricting member 300 and a spacer 270.
  • the compression member 202 includes a funnel 206 having a substantially frusto-conical shape with a large diameter at a first end 208 and a smaller diameter at a second end 210. The diameter of the funnel 206 may decrease uniformly from the first end 208 to the second end 210 to compress the valve 100 as it is advanced through the compression member 202.
  • the compression member 202 is preferably made of a substantially rigid material, and may be wholly or partly made of a transparent plastic, such as polycarbonate or acrylic, to allow viewing of the valve 100 during loading.
  • the compression member 202 may further include an annular rim 214 extending from the first end 208 of the funnel 206 for joining the compression member to the support member 204 as described below.
  • the rim 214 may include a plurality of slots 228 disposed around its outer periphery. While the drawings show slots 228 that are substantially P-shaped, the slots may have any other shapes suitable for securely holding the compression member 202 to the support member 204.
  • the rim 214 may include four such slots 228, or more or less than four. Regardless of the number or slots 228, adjacent slots are preferably spaced equidistantly from each other.
  • the compression member 202 also may include a tubular extension 216 projecting from the second end 210 of the funnel 206.
  • the tubular extension 216 has an opening 218 therethrough in communication with the interior of funnel 206.
  • the opening 218 is sized and shaped to receive the distal sheath 30 of the delivery device 10 therein.
  • the cross-section of the tubular extension 216 is preferably substantially circular, but may be oblong, oval, elliptical, or polygonal.
  • the support member 204 is preferably made in whole or in part of a substantially rigid material, and includes a body 219 having a substantially flat or planar bottom support surface 220 and a top end 221.
  • Body 219 has an outer wall 232 and a generally rectangular aperture 230 extending therethrough.
  • Aperture 230 has a generally cylindrical central portion 239 sized and shaped to receive at least a portion of the tip 32 of the delivery device 10 therein.
  • a recess 226 extends downwardly from the top end 221 of the body 219 concentrically with bore 230 so as to define a support surface 244 at a spaced distance from the top end.
  • Recess 226 has a diameter and a depth defined by support surface 244 sufficient to receive at least a portion of the annulus section 106 of the stent 102 in an expanded condition.
  • the outer wall 232 of body 219 does not extend continuously around the body, but rather may be interrupted by a plurality of inwardly curved indentations 242 which divide the outer wall into a plurality of wall segments 233, only two of which are shown in FIG. 6A .
  • FIG. 6A depicts a support member 204 having four indentations 242 evenly spaced around the periphery of body 219, it is contemplated that the support member may be provided with more or less than four such indentations. Indentations 242 facilitate the grasping of support member 204.
  • body 219 may include a plurality of recesses 235 extending inwardly from the bottom support surface 220. Recesses 235 reduce the mass of body 219 and facilitate the manufacturing process by eliminating excessively thick portions of the body.
  • outer wall segments 233 of body 219 do not extend all the way to the top end 221 of the body, but rather terminate at their top ends at a continuous wall 222 oriented at an oblique angle to the outer wall 232.
  • outer wall segments 233 each include a radially projecting supporting plate 234, the bottom surfaces of which are substantially coplanar with the bottom support surface 220 of body 219.
  • At least one pin 240 may protrude radially outward from each outer wall segment 233.
  • Pins 240 are preferably spaced a sufficient distance from supporting plates 234 and sized and shaped to be received in the slots 228 of the compression member 202 to join the compression member and the support member 204 together. When joined together, the compression member 202 and the support member 204 collectively define a partial loading assembly 201.
  • FIG. 7 illustrates a spacer 270 which optionally may be used in connection with support member 204 when a relatively small valve 100 is to be loaded into delivery device 10 using loading assembly 200.
  • Spacer 270 has a generally flat annular portion 272 with a central aperture 274 sized and shaped to receive at least a portion of the tip 32 of the delivery device 10 therethrough.
  • Each leg in a pair of resilient legs 276 has a tapered surface 278 adjacent its free end which terminates at a spaced distance from the free end in a retention surface 280.
  • Spacer 270 may be used to reduce the overall depth of the recess 226 in support member 204. Thus, spacer 270 may be inserted into recess 226 with legs 276 projecting into aperture 230.
  • FIGS. 8 and 9 illustrate a constricting member 300 designed to minimize the flaring of the distal end 21 of the distal sheath 30 during loading of a prosthetic heart valve into the compartment 23 of delivery device 10.
  • the constricting member 300 may be wholly or partly made of a transparent plastic, such as polycarbonate or acrylic, to allow viewing of the delivery device 10 during loading and includes a tubular member 302 having a central lumen 304 sized and shaped to slidingly receive at least the distal sheath 30 of the delivery device 10.
  • the constricting member 300 may have an enlarged head 308 with a counterbore 316 formed therein.
  • the counterbore 316 may have a diameter that is larger than the diameter of lumen 304, and in particular, may be sized and shaped to receive the tubular extension 216 of the compression member 202.
  • the diameter of counterbore 316 is only slightly larger than the outer diameter of the tubular extension 216 so as to create a friction fit therebetween.
  • constricting member 300 may have a tapered portion 310.
  • tapered portion 310 may have an inner surface 312 which tapers from a larger diameter at its end adjacent the counterbore 316 to a smaller diameter at its other end to help compress valve 100 further during loading into delivery device 10.
  • the constricting member 300 may further include a transition portion 320 disposed between the tapered portion 310 and the tubular member 302.
  • the transition portion 320 may have a substantially constant inner diameter sized and shaped to receive at least the distal sheath 30 of the delivery device 10.
  • the inner diameter of the transition portion 320 may be slightly smaller than the diameter of lumen 304 and slightly larger than the outer diameter of the distal sheath 30 in order to substantially prevent or minimize the flaring of the distal end 21 of the distal sheath 30 while the valve 100 is loaded in the delivery device 10, as discussed in detail below.
  • the larger diameter of the lumen 304 allows a user to easily slide the constricting member 300 over the distal sheath 30 of the delivery device 10.
  • the transition portion 320 may have an inner diameter which tapers downwardly from a slightly larger diameter at an end 313 thereof to a slightly smaller diameter at an end 315 thereof to accommodate small variations in the outer diameter of the distal sheath 30.
  • An annular groove or other indicator line 324 may extend partly or entirely around the outer periphery of the tubular member 302 at the junction between the tapered portion 310 and the transition portion 320.
  • Another annular groove or indicator line 325 may extend partly or entirely around the outer periphery of the tubular member 302 at a spaced distance from the first line 324. Lines 324 and 325 mark the area in which the user should place the distal end 21 of the distal sheath 30 during the loading procedure.
  • using the constricting member 300 to help load the valve 100 into the delivery device 10 reduces the loading forces (i.e., the forces required to load the valve into the delivery device) and reduces flaring of the distal end 21 of the distal sheath 30.
  • FIG. 10 shows an assembled loading assembly 200 including the compression member 202 of FIG. 5 , the support member 204 of FIG. 6 and the constricting member 300 of FIG. 8 .
  • the constricting member 300 is connected by its enlarged head 308 to the tubular extension 216 of the compression member 202, and the compression member 202 is locked to the support member 204.
  • the pins 240 of the support member are inserted into the slots 228 of the compression member, and the compression member is turned relative to the support member to slide the pins toward the closed ends of the slots.
  • the pins 240 and the slots 228 together form a locking mechanism 248.
  • any other known locking mechanisms may be employed to securely lock the compression member 202 to the support member 204.
  • the loading assembly 200 may be used to load the collapsible prosthetic heart valve 100 into a delivery device 10.
  • the spacer 270 is first assembled in the recess 226 of the support member 204 to decrease the overall depth of the recess. Then, as shown in FIG. 11 , with the support member 204 on a flat surface, at least a portion of the annulus section 106 of the stent 102 may be placed within the recess 226 of the support member until the end of the stent contacts support surface 282 on spacer 270.
  • the compression member 202 may then be placed over the aortic section 108 of the stent 102 so that the aortic section of the stent is positioned within the funnel 206, as depicted in FIG. 12 . As shown in FIG. 13 , the compression member 202 and the support member 204 may then be pushed together, the tapered walls of the funnel 206 gradually compressing the valve 100 until a portion of the aortic section 108 of the stent 102 is forced into and through the opening 218 of the compression member.
  • the retainers 118 of the stent When a portion of the aortic section 108 of the stent 102 passes through the opening 218 of the compression member 202, the retainers 118 of the stent will protrude through the opening 218 and will be positioned closely adjacent to one another. Even though the heart valve being compressed is relatively small, the use of spacer 27 reduces the overall depth of recess 226 such that the retainers 118 of stent 102 will protrude from opening 218 when the stent is collapsed.
  • the pins 240 of the support member 204 will be positioned within the slots 228 of the compression member 202, and the members may be locked together by rotating the support member relative to the compression member, such that the pins 240 of the support member slide toward the closed ends of the slots 228 of the compression member.
  • the constricting member 300 may be placed over the delivery device 10 with the enlarged head 308 positioned closer to the tip 32 than to the hub or handle of the delivery device, and with the distal end 21 of the distal sheath 30 longitudinally positioned between indicator lines 324 and 325 of the constricting member. It will be appreciated that the constricting member 300 also may be placed over the delivery device 10 with the distal sheath 30 in the distalmost or closed position, and that the distal sheath subsequently may be moved to the proximal or open position.
  • a syringe S may be connected to the Y-connector 18 of the delivery device 10, as shown in FIG. 15B .
  • the syringe may be used to inject a sterile liquid, such as saline, into the proximal end of the delivery device and out through the open compartment 23, thereby flushing the air from the device.
  • a sterile liquid such as saline
  • the tip 32 and the support shaft 28 of the delivery device 10 may be inserted into the end of the collapsed valve 100 protruding from the opening 218 of the compression member 202.
  • the compression member 202 and the support member 204 may be squeezed closer together.
  • the compression member 202 and the support member 204 may move further toward one another.
  • a greater portion of the stent 102 is forced out through opening 218, causing the retainers 118 to begin to separate from one another, as illustrated in FIG. 14 .
  • the tip 32 and support shaft 28 of the delivery device 10 may then be inserted between the retainers 118 and into the end of the collapsed valve 100, as shown in FIG. 16 .
  • the partial loading assembly 201 then may be advanced along the support shaft 28 until the retainers 118 of the stent 102 are positioned over the retaining element 26 of the delivery device 10.
  • the partial loading assembly 201 may be twisted as needed to align the retainers 118 with the recesses 27 in the retaining element 26. Positioning the retainers 118 within the recesses 27 of the retaining element 26 attaches the stent 102 to the delivery device 10, as seen in FIG. 17 . With the stent 102 attached to the retaining element 26, the constricting member 300 and the distal sheath 30 may be slid together toward the partial loading assembly 201 (or the inner tube 16 may be moved proximally relative to the constricting member 300 and the distal sheath 30) to about the position shown in FIG.
  • the distal sheath covers the retainers 118 of the stent, at the same time maintaining the distal end 21 of the distal sheath between indicator lines 324 and 325.
  • the tapered inner surface 312 of the enlarged head 308 facilitates the compression of the stent 102 as it moves into the constricting member 300.
  • the constricting member 300 and the partial loading assembly 201 may be joined to one another by assembly of the enlarged head 308 of the constricting member 300 to the tubular extension 216 of the compression member 202.
  • a sterile liquid such as saline
  • the support member 204 may be disassembled from the compression member 202 by first rotating the support member relative to the compression member, such that the pins 240 of the support member slide toward the open ends of the slots 228 of the compression member. This action unlocks the members from one another.
  • the support member 204 may then be moved away from the compression member 202 to disassemble the partial loading assembly 201. With the first open end 208 of the funnel 206 facing up, the sterile liquid may be dispensed into the compression member 202 through the first open end.
  • the sterile liquid may be dispensed into the compression member 202, such as through a syringe or a sterile container, until the funnel 206 is substantially filled, as shown in FIG. 18 .
  • the syringe may need to be refilled several times during the injection process in order to fill the funnel 206 with the sterile liquid.
  • any air bubbles in the sterile liquid within the funnel 206 may then be removed. It is important that little or no air be released into the human body during deployment and/or resheathing of the valve within the human heart, as the air may block vascular flow and cause tissue damage. For this reason, it is important to remove air bubbles from the delivery device 10 and the valve 100 before introducing them into the body. Testing has shown that, if the methods and assemblies described in this application are employed, minimal air will be released into the patient's bloodstream during valve deployment and resheathing.
  • Air bubbles formed in the sterile liquid near the space between the leaflets 112 and the cuff 114 of the valve 100 may be removed by using a tube or rod 400 or any other suitable atraumatic probe.
  • the tube 400 is commonly known in the art as a "leaflet tester" and may be formed of a substantially soft material, such as a soft polymer.
  • the tube 400 may be placed into the sterile liquid contained in the funnel 206 of the compression member 202 and used to probe areas of potential air entrapment, including gently agitating the liquid, as shown in FIG. 19 .
  • a syringe may be used to remove the air bubbles from the space near the retaining element 26 of the delivery device 10.
  • the syringe may be inserted into the space near the retaining element 26, and the sterile liquid near the retaining element 26 may be gently agitated with the syringe.
  • the valve 100 may be pulled into the distal sheath 30 until the valve is completely covered, as seen FIG. 20 .
  • the constricting member 300 and the compression member 202 may then be removed from the delivery device 10.
  • the inner tube 16 of the delivery device 10 may then be flushed with any suitable sterile liquid using, for example, a syringe.
  • a syringe may be connected to the hemostatic valve near the hub 14 of the delivery device 10, and then sterile liquid may be injected into the inner tube using the syringe.
  • the air bubbles may be removed from the distal sheath 30 by submerging the distal sheath, the compression member 202, and the constricting member 300 in a container holding sterile liquid, such as saline. Additional sterile liquid may be injected into the delivery device 10 through the Y-connector 18 using a syringe, as discussed above. The distal sheath 30 of the delivery device 10 may then be shaken and gently tapped against a hard surface to remove air bubbles from the valve 100. The valve 100 may then pulled into the distal sheath 30, as discussed above.
  • the stent 102 may be substantially cooled, which, depending on the materials forming the stent, may enable the stent to more easily deform.
  • a cold liquid such as saline solution, may be applied to the stent through the compression member 202 and the constricting member 300.
  • the cold liquid may then be introduced into the compression member 202 using any suitable apparatus. It will, of course, be appreciated that the cold liquid may thus serve two purposes-it may cool the stent 102, and it may serve as the deairing liquid in the deairing procedure described above.
  • the stent In order for the cooling of the stent 102 to be effective in making it easier for the stent to be completely covered by the distal sheath 30 of the delivery device 10, the stent should be cooled to a temperature below the transition temperature of the material forming the stent.
  • the "transition temperature" of a material is the temperature at which the material changes from one crystal state to another.
  • a saline solution at about 0°C may be used.
  • the stent 102 becomes plastic, enabling it to deform much more readily under the forces exerted by the movement of the distal sheath 30 thereover. Accordingly, after the stent 102 has been cooled below the transition temperature, the user may completely cover the stent 102 with the distal sheath 30 of the delivery device 10, as illustrated in FIG. 20 .
  • the distal sheath 30 of the delivery device 10 should be non-traumatic.
  • the distal sheath 30 may be made of soft polymeric material.
  • the distal end 21 of the distal sheath 30 may slightly expand or flare due to the pressure exerted by the self-expanding stent 102. Since the distal sheath 30 is typically formed from a soft polymer, the distal end 21 of the distal sheath may not return to its original shape once the distal sheath completely covers the valve 100.
  • the loading assembly 200 preferably includes the constricting member 300 described above.
  • the delivery device 10 and the loading assembly 200 may be provided together in the form of a kit.
  • the kit may include a delivery device 10 for delivering the heart valve into the patient, as well as a loading assembly 200 for loading the heart valve into the delivery device.
  • the loading assembly 200 would include all of the components necessary to load a heart valve into the delivery device, regardless of the size of heart valve to be deployed.
  • the loading assembly 200 would include a compression member 202, a support member 204, and a constricting member 300, as well as a spacer 270. In cases in which the heart valve to be deployed is relatively large, the spacer would not be used to reduce the depth of the recess 226 in support member 204.
  • spacer 270 may be used to assure that the retainers 118 of the heart valve stent 102 protrude through the opening 218 of compression member 202, as shown in FIG. 14 .
  • the kit may include multiple spacers 270, each spacer being sized for use with one or more heart valve sizes, the support surface or other surface of each spacer being marked with an indicia of the valve size that spacer is intended to be used with.
  • the spacer could be color-coded for use with one or more heart valve sizes.
  • the thickness of annular portion 272 may differ from one spacer 270 to another so as to reduce the depth of recess 226 by an appropriate amount to accommodate the size of the particular heart valve being loaded into delivery device 10.
  • the assemblies of the present invention readily compress collapsible prosthetic heart valves for loading into devices that deliver the heart valve to an implantation site in a patient.

Claims (15)

  1. Anordnung (200) zum Laden einer selbstexpandierenden künstlichen Herzklappe in eine Einführungsvorrichtung, Folgendes umfassend:
    ein Kompressionselement (202) mit einem ersten offenen Ende (208) mit einem ersten Durchmesser, einem zweiten offenen Ende (210) mit einem zweiten Durchmesser, der kleiner ist als der erste Durchmesser, und einer Wand (206), deren Durchmesser vom ersten offenen Ende zum zweiten offenen Ende abnimmt, wobei die Wand einen offenen Raum definiert, der angepasst ist, um die Herzklappe aufzunehmen;
    ein Stützelement (204) mit einer Basis an einem ersten Ende und einer Aussparung (226) an einem zweiten Ende (221), wobei die Aussparung eine feste Tiefe zwischen einer Stützfläche (244) der Aussparung und einem offenen Ende der Aussparung aufweist, wobei die Aussparung angepasst ist, ein Ende der Herzklappe aufzunehmen, wobei das Stützelement und das Kompressionselement zwischen einer Anfangsposition, in der die Basis des Stützelements relativ weit vom ersten offenen Ende des Kompressionselements entfernt ist, und einer Betriebsposition, in der die Basis des Stützelements relativ nah zum ersten offenen Ende des Kompressionselements ist, im Verhältnis zueinander bewegt werden können, wobei das Bewegen des Stützelements und des Kompressionselements aus der Anfangsposition in die Betriebsposition die Herzklappe durch den offenen Raum schiebt, so dass die Herzklappe durch die sich verjüngende Wand des Kompressionselements radial komprimiert wird, wenn die Herzklappe sich durch den offenen Raum hindurch bewegt;
    ein zusammenpressendes Element (300) mit einem ersten Ende und einem zweiten Ende, wobei das zweite Ende (306) des zusammenpressenden Elements so bemessen ist, dass es die komprimierte Herzklappe vom zweiten offenen Ende des Kompressionselements aufnimmt; dadurch gekennzeichnet, dass es ferner Folgendes umfasst:
    ein Distanzstück (270) zum Einsetzen in die Aussparung, so dass die Aussparung eine Tiefe zwischen einer Stützfläche des Distanzstücks und dem offenen Ende der Aussparung aufweist, die geringer ist als die feste Tiefe.
  2. Anordnung nach Anspruch 1, ferner umfassend:
    eine röhrenförmige Verlängerung (216) am zweiten offenen Ende (210) des Kompressionselements (202), wobei die röhrenförmige Verlängerung ein darin verlaufendes Lumen aufweist; und
    eine erste Dichtung, die angepasst ist, um zwischen der Einführungsvorrichtung und der röhrenförmige Verlängerung des Kompressionselements eingesetzt zu werden.
  3. Anordnung nach Anspruch 1, ferner umfassend eine röhrenförmige Verlängerung (216) am zweiten Ende des Kompressionselements, wobei die röhrenförmige Verlängerung ein darin verlaufendes Lumen aufweist, wobei das Lumen einen Durchmesser aufweist, der im Wesentlichen dem zweiten Durchmesser des Kompressionselements entspricht.
  4. Anordnung nach Anspruch 3, wobei das zweite Ende (306) des zusammenpressenden Elements (300) zum Zusammensetzen mit der röhrenförmigen Verlängerung (216) bemessen und geformt ist.
  5. Anordnung nach Anspruch 1, ferner umfassend eine Verriegelungsanordnung zum Verriegeln des Kompressionselements (202) mit dem Stützelement (204).
  6. Anordnung nach Anspruch 5, wobei die Verriegelungsanordnung ein Steckelement am Stützelement oder am Kompressionselement und ein Buchsenelement am anderen des Stützelements oder Kompressionselements zum Zusammenpassen mit dem Steckelement aufweist.
  7. Anordnung nach Anspruch 6, wobei das Steckelement mehrere Stifte (240) aufweist, die sich in radialen Richtungen von der Längsachse des Stützelements oder des Kompressionselements erstrecken, und das Buchsenelement mehrere Merkmale (228) am anderen des Stützelements oder Kompressionselements aufweist, die angepasst sind, mit den mehreren Stiften zusammen zu passen.
  8. Anordnung nach Anspruch 1, wobei das Stützelement (204) eine Durchgangsbohrung (230) aufweist, die sich von der Basis zur Aussparung erstreckt, wobei die Durchgangsbohrung so bemessen ist, dass sie eine Spitze der Einführungsvorrichtung dadurch aufnimmt.
  9. Anordnung nach Anspruch 8, wobei das Distanzstück (270) lösbar mit der Durchgangsbohrung (230) verbunden werden kann.
  10. Verfahren zum Laden einer selbstexpandierenden künstlichen Herzklappe in eine Einführungsvorrichtung, wobei die Einführungsvorrichtung Folgendes umfasst: eine Spitze, ein Halteelement, eine Kammer, die zwischen der Spitze und dem Halteelement definiert ist und angepasst ist, die Herzklappe aufzunehmen, und eine distale Hülse, die zwischen einer geschlossenen, die Kammer vollständig abdeckenden Position und einer offenen, die Kammer freigebenden Position bewegt werden kann, und wobei die Herzklappe einen Stent, eine vom Stent getragene Ventilanordnung und zumindest einen Halter an einem Ende des Stents aufweist, wobei die Herzklappe einen expandierten Zustand und einen zusammengefalteten Zustand besitzt, wobei das Verfahren Folgendes umfasst:
    Konfigurieren eines Stützelements zum Aufnehmen eines Endes der Herzklappe, wobei das Stützelement eine Basis an einem ersten Ende und eine Aussparung an einem zweiten Ende aufweist, wobei die Aussparung eine feste Tiefe zwischen einer Stützfläche der Aussparung und einem offenen Ende der Aussparung aufweist, wobei der Schritt des Konfigurierens das Einsetzen eines Distanzstücks in die Aussparung umfasst, so dass die Aussparung zwischen einer Stützfläche des Distanzstücks und dem offenen Ende der Aussparung eine Tiefe aufweist, die geringer ist als die feste Tiefe;
    Einsetzen des Endes der Herzklappe im expandierten Zustand in die Aussparung des Stützelements;
    Vorschieben des Stützelements und eines Kompressionselements zueinander, wobei das Kompressionselement eine Innenfläche aufweist, deren Durchmesser von einem ersten offenen Ende zu einem zweiten offenen Ende gleichmäßig abnimmt, wobei der Schritt des Vorschiebens das Vorschieben der Herzklappe durch das Kompressionselement beinhaltet, bis der zumindest eine Halter von dem zweiten offenen Ende des Kompressionselements vorsteht;
    Anordnen der Einführungsvorrichtung in einer Anfangsposition in einem zusammenpressenden Element, wobei das zusammenpressende Element ein erstes Ende, ein zweites Ende und einen längliche, röhrenförmigen Abschnitt zwischen dem ersten Ende und dem zweiten Ende aufweist, wobei bei der Einführungsvorrichtung in der Anfangsposition die distale Hülse in der offenen Position vorliegt und das Halteelement außerhalb des zusammenpressenden Elements angeordnet ist;
    Anbringen des zumindest einen Halters der Herzklappe am Halteelement der Einführungsvorrichtung; und
    Bewegen der distalen Hülse der Einführungsvorrichtung in die geschlossene Position, währenddessen die Herzklappe durch das zweite offene Ende des Kompressionselements und in den länglichen, röhrenförmigen Abschnitt des Kompressionselements vorgeschoben wird, um die Herzklappe im zusammengefalteten Zustand zu platzieren.
  11. Verfahren nach Anspruch 10, ferner umfassend das Füllen wenigstens eines Abschnitts des Kompressionselements mit einer sterilen Flüssigkeit, bevor die distale Hülse der Einführungsvorrichtung in die geschlossene Position bewegt wird, um Luft aus der Herzklappe und der Einführungsvorrichtung zu entfernen.
  12. Verfahren nach Anspruch 10, ferner umfassend das Zusammenfügen des zusammenpressenden Elements mit dem Kompressionselement, nachdem der wenigstens eine Halter der Herzklappe am Halteelement der Einführungsvorrichtung angebracht worden ist.
  13. Verfahren nach Anspruch 10, ferner umfassend das Verbinden des Stützelements mit dem Kompressionselement nach dem Schritt des Vorschiebens.
  14. Kit zum Einführen einer selbstexpandierenden künstlichen Herzklappe in eine Implantationsstelle in einem Patienten, wobei die Herzklappe eine von mehreren Größen aufweisen kann, wobei das Kit Folgendes umfasst:
    eine Einführungsvorrichtung (10), die Folgendes umfasst: eine Spitze (32), ein Halteelement (26), eine Kammer (23), die zwischen der Spitze und dem Halteelement definiert ist und angepasst ist, die Herzklappe aufzunehmen, und eine distale Hülse (30), die zwischen einer geschlossenen, die Kammer vollständig abdeckenden Position und einer offenen, die Kammer freigebenden Position bewegt werden kann; und eine Anordnung nach Anspruch 1,
    wobei die feste Tiefe der Aussparung (226) des Stützelements der Anordnung zur Verwendung mit einer Herzklappe mit einer ersten komprimierten Länge angepasst ist und wobei die zweite Tiefe der Aussparung zur Verwendung einer Herzklappe mit einer komprimierten Länge, die geringer ist als die erste komprimierte Länge. angepasst ist.
  15. Kit nach Anspruch 14, ferner umfassend mehrere Distanzstücke, die angepasst sind, um in die Aussparung eingesetzt zu werden, wobei jedes Distanzstück angepasst ist, um die Tiefe der Aussparung um eine vorgegebene Größe zu verringern, wobei die vorgegebene Größe für ein Distanzstück sich von der vorgegebenen Größe für jedes der anderen Distanzstücke unterscheidet.
EP12746185.3A 2011-07-28 2012-07-26 System zum laden einer faltbaren herzklappe Active EP2736454B1 (de)

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US201161512637P 2011-07-28 2011-07-28
US13/535,591 US8893370B2 (en) 2011-07-28 2012-06-28 System for loading a collapsible heart valve
PCT/US2012/048298 WO2013016513A1 (en) 2011-07-28 2012-07-26 System for loading a collapsible heart valve

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US11419720B2 (en) 2010-05-05 2022-08-23 Neovasc Tiara Inc. Transcatheter mitral valve prosthesis
US11413139B2 (en) 2011-11-23 2022-08-16 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US11497602B2 (en) 2012-02-14 2022-11-15 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US10940001B2 (en) 2012-05-30 2021-03-09 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
US11617650B2 (en) 2012-05-30 2023-04-04 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
US11389294B2 (en) 2012-05-30 2022-07-19 Neovasc Tiara Inc. Methods and apparatus for loading a prosthesis onto a delivery system
US11389291B2 (en) 2013-04-04 2022-07-19 Neovase Tiara Inc. Methods and apparatus for delivering a prosthetic valve to a beating heart
US11357622B2 (en) 2016-01-29 2022-06-14 Neovase Tiara Inc. Prosthetic valve for avoiding obstruction of outflow
US11464631B2 (en) 2016-11-21 2022-10-11 Neovasc Tiara Inc. Methods and systems for rapid retraction of a transcatheter heart valve delivery system
US10856984B2 (en) 2017-08-25 2020-12-08 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US11793640B2 (en) 2017-08-25 2023-10-24 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US11737872B2 (en) 2018-11-08 2023-08-29 Neovasc Tiara Inc. Ventricular deployment of a transcatheter mitral valve prosthesis
US11602429B2 (en) 2019-04-01 2023-03-14 Neovasc Tiara Inc. Controllably deployable prosthetic valve
US11491006B2 (en) 2019-04-10 2022-11-08 Neovasc Tiara Inc. Prosthetic valve with natural blood flow
US11779742B2 (en) 2019-05-20 2023-10-10 Neovasc Tiara Inc. Introducer with hemostasis mechanism
US11311376B2 (en) 2019-06-20 2022-04-26 Neovase Tiara Inc. Low profile prosthetic mitral valve
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US20130166020A1 (en) 2013-06-27
CA2842074A1 (en) 2013-01-31
AU2012286876B2 (en) 2014-11-06
AU2012286876A1 (en) 2014-02-20
JP2014529316A (ja) 2014-11-06
JP6042432B2 (ja) 2016-12-14
CA2842074C (en) 2016-02-16
BR112014002016A2 (pt) 2017-02-21
CR20140025A (es) 2014-03-05
EP2736454A1 (de) 2014-06-04
US8893370B2 (en) 2014-11-25
ES2556469T3 (es) 2016-01-18
WO2013016513A1 (en) 2013-01-31

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